Table 2.

Investigator-assessed best overall response

Investigator-assessed responsePrimary cohort (N = 24)ITT population (N = 55)BRAF V600E evaluable population (n = 50)
Best response, n (%)    
CR ± MRD 18 (75.0) 36 (65.5) 32 (64.0) 
CR without MRD 4 (16.7)  5 (9.1)  4 (8.0)  
 5 (20.8)  7 (12.7)  6 (12.0)  
CR with MRD 5 (20.8)  9 (16.4)  7 (14.0)  
 13 (54.2) 27 (49.1) 25 (50.0) 
PR 4 (16.7) 13 (23.6) 13 (26.0) 
Minor response 1 (4.2) 4 (7.3) 4 (8.0) 
Stable disease 
Progressive disease 1 (4.2) 1 (1.8) 1 (2.0) 
Not evaluable 1 (1.8) 
ORR (CR ± MRD + PR), n (%) 22 (91.7) 49 (89.1) 45 (90.0) 
95% CI§  73.0-99.0 77.8-95.9 78.2-96.7 
Investigator-assessed responsePrimary cohort (N = 24)ITT population (N = 55)BRAF V600E evaluable population (n = 50)
Best response, n (%)    
CR ± MRD 18 (75.0) 36 (65.5) 32 (64.0) 
CR without MRD 4 (16.7)  5 (9.1)  4 (8.0)  
 5 (20.8)  7 (12.7)  6 (12.0)  
CR with MRD 5 (20.8)  9 (16.4)  7 (14.0)  
 13 (54.2) 27 (49.1) 25 (50.0) 
PR 4 (16.7) 13 (23.6) 13 (26.0) 
Minor response 1 (4.2) 4 (7.3) 4 (8.0) 
Stable disease 
Progressive disease 1 (4.2) 1 (1.8) 1 (2.0) 
Not evaluable 1 (1.8) 
ORR (CR ± MRD + PR), n (%) 22 (91.7) 49 (89.1) 45 (90.0) 
95% CI§  73.0-99.0 77.8-95.9 78.2-96.7 

Patients with negative IHC of BM biopsy.

Patients negative for BM aspirate FC.

Patients had negative IHC and/or negative FC results in PB and BM specimens.

§

Exact 2-sided 95% CI based on the Clopper-Pearson method.

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